[PDF] National Healthcare Safety Network Biovigilance Component

View - Download National Healthcare Safety Network Biovigilance Component

Previous PDF

Next PDF

NHSN Biovigilance Component

Hemovigilance Module Surveillance Protocol v2.8

Page 1 of 31

February 2023

National Healthcare Safety Network

Biovigilance Component

Hemovigilance Module

Surveillance Protocol

Division of Healthcare Quality Promotion

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

Atlanta, GA, USA

NHSN Biovigilance Component

Hemovigilance Module Surveillance Protocol v2.8

Page 2 of 31

February 2023

Version History

Version Release Date Summary of Revisions

1.0 March 2009 First version publicly released.

1.1 June 2010 Revised background and text in main body of document.

Revised case definition criterion based on WG recommendations, pilot responses, and CDC recommendations. Updated FNHTR definition to allow reaction without documented fever. Defined hypotension for infants and small children

Clarified TAGVHD probable and possible criteria.

1.2 July 2010 Corrected definition of hypoxemia in glossary of terms.

1.3 June 2011 Added version number and version history summary.

Summarized introduction and background sections for brevity. Reorganized surveillance methods section for ease of use. Clarified reporting of "approved deviation" incidents. Clarified use of "other" in adverse reaction reporting. Clarified use of "doubtful" or "ruled out" in adverse reaction reporting. Added denominator summary options to list of available analysis reports.

Replaced < and > signs with appropriate text for.

Added "cessation of" to time frame requirements in case definitions. NEW probable case definition category for allergic reaction reporting. Updated adult hypotensive reaction case definition to align with updated ISBT definition.

NEW possible imputability category for DHTR.

DELETED possible case definition category for hypotensive reaction. NEW probable imputability category for PTP reaction. Updated and clarified imputability categories for TAGVHD reaction. DELETED possible case definition category for TRALI.

Simplified imputability criteria for TTI.

Clarified case definition and imputability criteria for all adverse reactions.

2.0 January 2013 Complete revision of organization and presentation of information

Major change in incident reporting requirements. With this release, only incidents that relate to an adverse patient reaction are required for participation. Major change in adverse reaction reporting requirements. With this release, minor allergic reactions are no longer required for participation. Combined the signs/symptoms with laboratory/radiology columns in case definition tables for clarity. Listed criteria in alphabetical order where possible for consistency and clarity. Moved general severity requirements from the appendix to the criteria tables where they were previously missing. Re-ordered adverse reaction tables to put respiratory reactions first. Added Imputability criteria of Doubtful, Ruled Out, and Not Determined to the case definition tables as OPTIONAL reporting categories. The reporting is not a change, but including them in the table is new. They were added for clarity. Added specific AHTR criteria to allow for reporting of non-immune mediated reactions. Added a separate case definition table for Other and Unknown reactions. These categories are available for OPTONAL use.

Removed redundant and unnecessary appendices.

2.1 August 2013 Minor revisions to verbiage throughout for clarity.

Added definitions and illustration of surveillance key terms in Section 1. Added clarification of surveillance vs. clinical definitions in Section 1. Added less-specific case definition categories for OPTIONAL reporting of cases that do not fully meet CDC case criteria for the following reactions: hypotension, febrile non-hemolytic, acute hemolytic and delayed hemolytic.

NHSN Biovigilance Component

Hemovigilance Module Surveillance Protocol v2.8

Page 3 of 31

February 2023

Version Release Date Summary of Revisions

Added a possible case definition category for TTI for OPTIONAL reporting of syndromic cases that are not laboratory confirmed.

2.1.1 September 2013 Updated diagram in Section 1 and added version history for v2.0 and v2.1.

2.1.2 January 2014 Updated the incident codes in Section 4 and included required reporting of discards

and total crossmatch procedures on the Monthly Reporting Denominators form in

Section 5.

2.1.3 August 2014 Added a suggested citation for the surveillance protocol in Section 1. Updated the

acute hemolytic case definition in Section 3 for clarity. Updated the reporting requirements in Section 5 for clarity.

2.2 January 2016 Updated contact instructions for consistency in Section 1: User support

Updated version number in Section 1: Suggested Citation Remove Root Cause Analysis Result from Section 4: Incident Glossary Updated denominator report description to include Pathogen-reduced products in

Section 5: Required Reporting

2.3 June 2016 Updated denominator report description to include Table 3 description.

2.4 January 2017 Section 1: Setting - Added additional Annual Facility form for Non-Acute Care

Facilities to report.

Section 2: Annual Facility Survey - Added information about Non-Acute Care Facility Annual Facility Survey, Added links to the Annual Facility Survey - Non- Acute Care Facility form and table of instructions for clarity.

2.5 January 2018 Section 1: Training, User Support, Data Reporting - Minor language changes for

clarification Section 3: Adverse Reaction Classification - Added information about module- generated classification designations. Adverse Reaction Glossary: Updated the definition of fever to be consistent with

FNHTR criteria.

2.5.2. April 2018 Section 4: Incident codes - UT 06 - “incompatible" replaced with “unapproved"

2.6 March 2021 Section 3: Adverse Reaction Classification - Updated case definition criteria for

TACO reactions

2.7 October 2022 Section 4: Updated the incident codes in Section 4 to include under-transfusion with

the creation of a new process code: no blood (NB) and four incident codes

2.8 February 2023 Section 4: Optional Reporting: Clarification regarding analysis of optional reporting

NHSN Biovigilance Component

Hemovigilance Module Surveillance Protocol v2.8

Page 4 of 31

February 2023

Table of Contents

Section 1. Hemovigilance Module Surveillance Overview .........................................5

Section 2. Hemovigilance Module Annual

Facility Survey .........................................7 Section 3: Hemovigilance Module Adverse Reactions ...............................................8

Adverse Reaction Case Classification Criteria Tables .................................................... 9

Transfusion

-associated circulatory overload (TACO) ....................................................................... 9

Transfusion

-related acute lung injury (TRALI) .................................................................................10

Transfusion

-associated dyspnea (TAD) ..........................................................................................11

Allergic reaction ..............................................................................................................................12

Hypotensive transfusion reaction ....................................................................................................13

Febrile non

-hemolytic transfusion reaction (FNHTR) .......................................................................14

Acute hemolytic transfusion reaction (AHTR) ..................................................................................15

Delayed hemolytic transfusion

reaction (DHTR) ..............................................................................16

Delayed serologic transfusion

reaction (DSTR) ...............................................................................17

Transfusion

-associated graft vs. host disease (TAGVHD) ...............................................................18

Post transfusion purpura (PTP) ......................................................................................................19

Transfusion

-transmitted infection (TTI)............................................................................................20

Other or Unknown ..........................................................................................................................22

Adverse

Reaction Glossary ........................................................................................... 23

Section 4. Hemovigilance Module Incidents ..............................................................24

Incident Codes ............................................................................................................... 25

Occupation Codes.......................................................................................................... 28

Incident Glossary ...........................................................................................................

30

Section 5. Hemovigilance Module Denominators ......................................................31

NHSN Biovigilance Component

Hemovigilance Module Surveillance Protocol v2.8

Page 5 of 31

February 2023

Section 1. Hemovigilance Module Surveillance Overview

Purpose

The National Healthcare Safety Network (NHSN) Hemovigilance (HV) Module was created to implement national surveillance of transfusion -associated adverse events aimed at improving patient safety,

minimizing morbidity and mortality of transfusion recipients, and identifying emerging complications and

pathogens associated with blood transfusion.

Settings

The Hemovigilance Module may be used by any U.S. healthcare facility where blood components and manufactured blood products are transfused (e.g., adult or pediatric facilities, acute or non -acute care

facilities). Surveillance must be performed facility-wide, including patient care areas for emergency,

general medical, and surgical patients; obstetrics and gynecology; orthopedics, oncology, and other chronic diseases; and any other facility location where transfusions are administered.

Methods

The NHSN Hemovigilance Module requires comprehensive surveillance of patients and blood

components throughout the transfusion process, from product receipt to administration to the patient.

Participation in the NHSN Hemovigilance Module requires reporting of all adverse transfusion reactions

and reaction -associated incidents that occur for patients transfused at or by your facility as well as a monthly summary of components transfused or discarded and patient samples collected for type and screen or crossmatch.

Data Collection

NHSN is a web-based application used by healthcare facilities to report surveillance data. Paper

versions of all forms are used to collect data prior to data entry in the NHSN Hemovigilance Module. The

paper forms are available on the NHSN Blood Safety Surveillance website. A link to the appropriate form(s) and their instructions is provided in the following sections for your convenience. T raining

Training presentations are available on the

NHSN Blood Safety Surveillance website

for self-pac e d training and must be reviewed prior to participating in the Hemovigilance Module. CDC also provides webinar and in -person training opportunities for current NHSN participants. These opportunities are communicated through the NHSN quarterly newsletter and emails from the Hemovigilance Team. U ser Support CDC is available to answer your questions about the Surveillance Protocol and to help navigate the

NHSN web application. Please contact us at

nhsn@cdc.gov. Type HE

M OVIGILANCE in the subject line

for quickest routing to the Hemovigilance Team. S uggested Citation for the Hemovigilance Module Surveillance Protocol U.S. Centers for Disease Control and Prevention. The National Healthcare Safety Network (NHSN) Manual: Biovigilance Component v2.5. Atlanta, GA: Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases. Available at: http://www.cdc.gov/nhsn/PDFs/Biovigilance/BV-HV-protocol-current.pdf. Accessed [enter date].

NHSN Biovigilance Component

Hemovigilance Module Surveillance Protocol v2.8

Page 6 of 31

February 2023

Key Terms (see Fig. 1)

Adverse event: An unintended and undesirable occurrence before, during or after transfusion of blood or blood components. Adverse events include both incidents and adverse reactions. Adverse reaction: An undesirable response or effect in a patient temporally associated with the administration of blood or blood components. It may or may not be the result of an incident.

Incident: Any error or accident that could affect the quality or efficacy of blood, blood components,

or patient transfusions. It may or may not result in an adverse reaction in a transfusion recipient. Near miss: A subset of incidents that are discovered before the start of a transfusion that could have led to a wrongful transfusion or an adverse reaction in a transfusion recipient.

Data Reporting (See Fig. 1)

An annual facility demographic and practice survey for each calendar year of participation ALL adverse reactions defined in this protocol that follow transfusion at or by your facility ALL incidents (i.e., errors or accidents) associated with an adverse reaction The number of blood components transfused or discarded and patient samples collected for type and screen or crossmatch each month Figure 1. Venn diagram of NHSN Hemovigilance Module surveillance terms.

Transfusion-Related Activities

• Patient Sample Collection

• Sample Handling and Testing

• Inventory Management

• Patient Monitoring

Transfusion

• Number of Components

• Number of Patients Adverse Events

Reactions

Incidents

Near Miss Incidents

Incidents Related to Transfusion (No Adverse Reaction) Incidents Related to Transfusion and Adverse Reaction

Transfusion-Related

Activities

Transfusions

Incidents

Reactions

NHSN Biovigilance Component

Hemovigilance Module Surveillance Protocol v2.8

Page 7 of 31

February 2023

Section 2. Hemovigilance Module Annual Facility Survey

Required Reporting

Participating facilities must enter the Hemovigilance Module Annual Facility Survey at the time that they

enroll or activate the Biovigilance Component and at the beginning of each calendar year thereafter. The

survey is used by CDC to classify facilities for appropriate comparisons in aggregate data analyses and

to learn more about common practices among transfusion services. The data collected in the survey covers the previous calendar year. For example, if the facility is enrolling in NHSN for the first time in October of 2013, report information for January 2012 -December 2012 on the first Hemovigilance Module Annual Facility Survey. In January 2014, complete a new survey with data from January 2013 -December

2013. CDC recommends collecting all survey information on a paper form before attempting to enter

data into the web application.

As of January 2017, non

-acute care facilities are able to report hemovigilance data to NHSN. Non-acute care facilities should complete Annual Facility Survey for Non-acute care facility 57.306. This form contains questions tailored to non -acute care facilities. Users may refer to the Non-Acute Care Facility Table of Instructions form 57.306 for detailed instruction about data collection. Form CDC 57.300 Hemovigilance Module Annual Facility Survey - Acute Care Facility CDC 57.306 Hemovigilance Module Annual Facility Survey - Non-Acute Care Facility

Form Instructions

CDC 57.300 Hemovigilance Module Annual Facility Survey - Acute Care Facility Table of Instructions CDC 57.306 Hemovigilance Module Annual Facility Surveyquotesdbs_dbs50.pdfusesText_50

[PDF] définition hip hop

[PDF] définition historique de l internet

[PDF] definition laboratoire d'analyse médicale

[PDF] definition messagerie electronique

[PDF] définition mondialisation géographie terminale

[PDF] définition onde physique

[PDF] définition onde progressive

[PDF] définition onde transversale

[PDF] définition optique ondulatoire

[PDF] définition plan sénégal émergent

[PDF] définition pratique du suivi evaluation

[PDF] définition prescription médicale

[PDF] définition prévention santé environnement

[PDF] definition prf echographie

[PDF] définition produit de terroir maroc